Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary scheduling order.

SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this temporary scheduling order to schedule the synthetic
opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide
(4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl), and
its isomers, esters, ethers, salts and salts of isomers, esters, and
ethers, into schedule I pursuant to the temporary scheduling provisions
of the Controlled Substances Act. This action is based on a finding by
the Administrator that the placement of 4-fluoroisobutyryl fentanyl
into schedule I of the Controlled Substances Act is necessary to avoid
an imminent hazard to the public safety. As a result of this order, the
regulatory controls and administrative, civil, and criminal sanctions
applicable to schedule I controlled substances will be imposed on
persons who handle (manufacture, distribute, reverse distribute,
import, export, engage in research, conduct instructional activities or
chemical analysis, or possess), or propose to handle, 4-fluoroisobutyryl fentanyl.

DATES: This temporary scheduling order is effective May 3, 2017, until
May 3, 2019, unless it is extended for an additional year or a
permanent scheduling proceeding is completed. The DEA will publish a
document in the Federal Register announcing an extension or permanence.

Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811,
provides the Attorney General with the authority to temporarily place a
substance into schedule I of the CSA for two years without regard to
the requirements of 21 U.S.C. 811(b) if he finds that such action is
necessary to avoid an imminent hazard to the public safety. 21 U.S.C.
811(h)(1). In addition, if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend
the temporary scheduling \1\ for up to one year. 21 U.S.C. 811(h)(2).

\1\ Though DEA has used the term "final order" with respect to
temporary scheduling orders in the past, this notice adheres to the
statutory language of 21 U.S.C. 811(h), which refers to a
"temporary scheduling order." No substantive change is intended.

Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

[[Page 20545]]

Background

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of his intention to temporarily place a substance
into schedule I of the CSA.\2\ The Administrator transmitted the notice
of intent to place 4-fluoroisobutyryl fentanyl into schedule I on a
temporary basis to the Assistant Secretary by letter dated January 5,
2017. The Assistant Secretary responded to this notice by letter dated
January 17, 2017, and advised that based on review by the Food and Drug
Administration (FDA), there are currently no investigational new drug
applications or approved new drug applications for 4-fluoroisobutyryl
fentanyl. The Assistant Secretary also stated that the HHS has no
objection to the temporary placement of 4-fluoroisobutyryl fentanyl
into schedule I of the CSA. The DEA has taken into consideration the
Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). 4-Fluoroisobutyryl fentanyl is not currently listed in any schedule under
the CSA, and no exemptions or approvals are in effect for 4-fluoroisobutyryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355.
The DEA has found that the control of 4-fluoroisobutyryl fentanyl in
schedule I on a temporary basis is necessary to avoid an imminent
hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A),
a notice of intent to issue a temporary order to schedule 4-fluoroisobutyryl fentanyl was published in the Federal Register on
March 23, 2017. 82 FR 14842.

\2\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS
in carrying out the Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of the HHS has delegated to the Assistant Secretary for
Health of the HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.

To find that placing a substance temporarily into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's
history and current pattern of abuse; the scope, duration and
significance of abuse; and what, if any, risk there is to the public
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary
scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1).
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1).

Available data and information for 4-fluoroisobutyryl fentanyl,
summarized below, indicate that this synthetic opioid has a high
potential for abuse, no currently accepted medical use in treatment in
the United States, and a lack of accepted safety for use under medical
supervision. The DEA's three-factor analysis, and the Assistant
Secretary's January 17, 2017, letter, are available in their entirety
under the tab "Supporting Documents" of the public docket of this
action at www.regulations.gov under FDMS Docket ID: DEA-2017-0004
(Docket Number DEA-452).

Factor 4. History and Current Pattern of Abuse

The recreational abuse of fentanyl-like substances continues to be
a significant concern. These substances are distributed to users, often
with unpredictable outcomes. 4-Fluoroisobutyryl fentanyl has recently
been encountered by law enforcement and public health officials and the
adverse health effects and outcomes are demonstrated by fatal overdose
cases. The documented negative effects of 4-fluoroisobutyryl fentanyl
are consistent with those of other opioids.

On October 1, 2014, the DEA implemented STARLiMS (a web-based,
commercial laboratory information management system) to replace the
System to Retrieve Information from Drug Evidence (STRIDE) as its
laboratory drug evidence data system of record. DEA laboratory data
submitted after September 30, 2014, are reposited in STARLiMS. Data
from STRIDE and STARLiMS were queried on December 21, 2016. STARLiMS
registered 21 reports containing 4-fluoroisobutyryl fentanyl, all
reported in 2016, from Florida, Maryland, Mississippi, New Jersey, New
York, Texas, and the District of Columbia. According to STARLiMS, the
first laboratory submission of 4-fluoroisobutyryl fentanyl occurred in
March 2016 in Maryland. The DEA is not aware of any laboratory
identifications of 4-fluoroisobutyryl fentanyl prior to 2016.

The National Forensic Laboratory Information System (NFLIS) is a
national drug forensic laboratory reporting system that systematically
collects results from drug chemistry analyses conducted by other
federal, state and local forensic laboratories across the country.
According to NFLIS, the only report of 4-fluoroisobutyryl fentanyl from
state or local forensic laboratories was recorded in August 2016 in
Pennsylvania. Due to normal lag time in reporting, NFLIS data from
August through November 2016 is incomplete.\3\

Evidence suggests that the pattern of abuse of fentanyl analogues,
including 4-fluoroisobutyryl fentanyl, parallels that of heroin and
prescription opioid analgesics. Seizures of 4-fluoroisobutyryl fentanyl
have been encountered in powder form and packaged similar to that of
heroin. 4-Fluoroisobutyryl fentanyl has been encountered as a single
substance as well as in combination with other substances of abuse,
including heroin, fentanyl, furanyl fentanyl, methamphetamine, and
cocaine. 4-Fluoroisobutyryl fentanyl has been connected to fatal
overdoses, in which insufflation and intravenous routes of
administration are documented.

Factor 5. Scope, Duration and Significance of Abuse

Reports collected by the DEA demonstrate 4-fluoroisobutyryl
fentanyl is being abused for its opioid properties. This abuse of 4-fluoroisobutyryl fentanyl has resulted in morbidity and mortality (see
DEA 3-Factor Analysis for full discussion). The DEA has received
reports for at least 62 confirmed fatalities associated with 4-fluoroisobutyryl fentanyl. Information on these deaths, occurring as
early as August 2016, was collected from post-mortem toxicology and
medical examiner reports by the DEA. These deaths were reported from,
and occurred in, Maryland. NFLIS and STARLiMS have a total of 22 drug
reports in which 4-fluoroisobutyryl fentanyl was identified in drug
exhibits submitted to forensic laboratories in 2016 from law
enforcement encounters in Florida, Maryland, Mississippi, New Jersey,
New York, Pennsylvania, Texas, and the District of Columbia. It is
likely that the prevalence of 4-fluoroisobutyryl fentanyl in opioid
analgesic-related emergency room admissions and deaths is underreported
as standard immunoassays may not differentiate this substance from
fentanyl.

The population likely to abuse 4-fluoroisobutyryl fentanyl overlaps
with

[[Page 20546]]

the population abusing prescription opioid analgesics and heroin. This
is evidenced by the routes of drug administration and drug use history
documented in 4-fluoroisobutyryl fentanyl fatal overdose cases. Because
abusers of 4-fluoroisobutyryl fentanyl are likely to obtain this
substance through unregulated sources, the identity, purity, and
quantity are uncertain and inconsistent, thus posing significant
adverse health risks to the end user. Individuals who initiate (i.e.
use a drug for the first time) 4-fluoroisobutyryl fentanyl abuse are
likely to be at risk of developing substance use disorder, overdose,
and death similar to that of other opioid analgesics (e.g., fentanyl,
morphine, etc.).

Factor 6. What, if Any, Risk There Is to the Public Health

4-Fluoroisobutyryl fentanyl exhibits pharmacological profiles
similar to that of fentanyl and other [micro]-opioid receptor agonists.
The toxic effects of 4-fluoroisobutyryl fentanyl in humans are
demonstrated by overdose fatalities involving this substance. Abusers
of 4-fluoroisobutyryl fentanyl may not know the origin, identity, or
purity of this substance, thus posing significant adverse health risks
when compared to abuse of pharmaceutical preparations of opioid
analgesics, such as morphine and oxycodone.

Based on information received by the DEA, the abuse of 4-fluoroisobutyryl fentanyl leads to the same qualitative public health
risks as heroin, fentanyl and other opioid analgesic substances. As
with any non-medically approved opioid, the health and safety risks for
users are great. The public health risks attendant to the abuse of
heroin and opioid analgesics are well established and have resulted in
large numbers of drug treatment admissions, emergency department
visits, and fatal overdoses.

4-Fluoroisobutyryl fentanyl has been associated with numerous
fatalities. At least 62 confirmed overdose deaths involving 4-fluoroisobutyryl fentanyl abuse have been reported from Maryland in
2016. As the data demonstrates, the potential for fatal and non-fatal
overdose exists for 4-fluoroisobutyryl fentanyl; thus, 4-fluoroisobutyryl fentanyl poses an imminent hazard to the public
safety.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety

In accordance with 21 U.S.C. 811(h)(3), based on the data and
information summarized above, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse of 4-fluoroisobutyryl
fentanyl pose an imminent hazard to the public safety. The DEA is not
aware of any currently accepted medical uses for this substance in
treatment in the United States. A substance meeting the statutory
requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be
placed into schedule I. Substances in schedule I are those that have a
high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
under medical supervision. Available data and information for 4-fluoroisobutyryl fentanyl indicate that this substance has a high
potential for abuse, no currently accepted medical use in treatment in
the United States, and a lack of accepted safety for use under medical
supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C.
811(h)(4), the Administrator, through a letter dated January 5, 2017,
notified the Assistant Secretary of the DEA's intention to temporarily
place this substance into schedule I. A notice of intent was
subsequently published in the Federal Register on March 23, 2017. 82 FR
14842.

Conclusion

In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator considered available data and
information, herein sets forth the grounds for his determination that
it is necessary to temporarily schedule 4-fluoroisobutyryl fentanyl
into schedule I of the CSA, and finds that placement of this synthetic
opioid into schedule I of the CSA is necessary to avoid an imminent
hazard to the public safety.

Because the Administrator hereby finds it necessary to temporarily
place this synthetic opioid into schedule I to avoid an imminent hazard
to the public safety, this temporary order scheduling 4-fluoroisobutyryl fentanyl will be effective on the date of publication
in the Federal Register, and will be in effect for a period of two
years, with a possible extension of one additional year, pending
completion of the regular (permanent) scheduling process. 21 U.S.C.
811(h)(1) and (2).

The CSA sets forth specific criteria for scheduling a drug or other
substance. Permanent scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done "on the record
after opportunity for a hearing" conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling
process of formal rulemaking affords interested parties with
appropriate process and the government with any additional relevant
information needed to make a determination. Final decisions that
conclude the permanent scheduling process of formal rulemaking are
subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders
are not subject to judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

Upon the effective date of this temporary order, 4-fluoroisobutyryl
fentanyl will become subject to the regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, importation,
exportation, engagement in research, and conduct of instructional
activities or chemical analysis with, and possession of schedule I
controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses), or
who desires to handle, 4-fluoroisobutyryl fentanyl must be registered
with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823,
957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of
May 3, 2017. Any person who currently handles 4-fluoroisobutyryl
fentanyl, and is not registered with the DEA, must submit an
application for registration and may not continue to handle 4-fluoroisobutyryl fentanyl as of May 3, 2017, unless the DEA has
approved that application for registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
Retail sales of schedule I controlled substances to the general public
are not allowed under the CSA. Possession of any quantity of this
substance in a manner not authorized by the CSA on or after May 3, 2017
is unlawful and those in possession of any quantity of this substance
may be subject to prosecution pursuant to the CSA.

2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle 4-fluoroisobutyryl
fentanyl, must surrender all quantities of currently held 4-fluoroisobutyryl fentanyl.

3. Security. 4-Fluoroisobutyryl fentanyl is subject to schedule I
security requirements and must be handled and stored pursuant to 21
U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93,
as of May 3, 2017.

[[Page 20547]]

4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of 4-fluoroisobutyryl fentanyl must be in
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR
part 1302. Current DEA registrants shall have 30 calendar days from May
3, 2017, to comply with all labeling and packaging requirements.

5. Inventory. Every DEA registrant who possesses any quantity of 4-fluoroisobutyryl fentanyl on the effective date of this order must take
an inventory of all stocks of this substance on hand, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants shall have 30 calendar days from the
effective date of this order to be in compliance with all inventory
requirements. After the initial inventory, every DEA registrant must
take an inventory of all controlled substances (including 4-fluoroisobutyryl fentanyl) on hand on a biennial basis, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.

6. Records. All DEA registrants must maintain records with respect
to 4-fluoroisobutyryl fentanyl pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR parts 1304, and 1312, 1317 and Sec. 1307.11.
Current DEA registrants shall have 30 calendar days from the effective
date of this order to be in compliance with all recordkeeping
requirements.

7. Reports. All DEA registrants who manufacture or distribute 4-fluoroisobutyryl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 1312 as of May 3, 2017.

8. Order Forms. All DEA registrants who distribute 4-fluoroisobutyryl fentanyl must comply with order form requirements
pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of
May 3, 2017.

9. Importation and Exportation. All importation and exportation of
4-fluoroisobutyryl fentanyl must be in compliance with 21 U.S.C. 952,
953, 957, 958, and in accordance with 21 CFR part 1312 as of May 3,
2017.

10. Quota. Only DEA registered manufacturers may manufacture 4-fluoroisobutyryl fentanyl in accordance with a quota assigned pursuant
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of May 3,
2017.

11. Liability. Any activity involving 4-fluoroisobutyryl fentanyl
not authorized by, or in violation of the CSA, occurring as of May 3,
2017, is unlawful, and may subject the person to administrative, civil,
and/or criminal sanctions.

Regulatory Matters

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a
temporary scheduling action where such action is necessary to avoid an
imminent hazard to the public safety. As provided in this subsection,
the Attorney General may, by order, schedule a substance in schedule I
on a temporary basis. Such an order may not be issued before the
expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
the proposed temporary scheduling order is transmitted to the Assistant
Secretary. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of the Administrative Procedure Act (APA) at 5
U.S.C. 553, do not apply to this temporary scheduling action. In the
alternative, even assuming that this action might be subject to 5
U.S.C. 553, the Administrator finds that there is good cause to forgo
the notice and comment requirements of 5 U.S.C. 553, as any further
delays in the process for issuance of temporary scheduling orders would
be impracticable and contrary to the public interest in view of the
manifest urgency to avoid an imminent hazard to the public safety.

Further, the DEA believes that this temporary scheduling action is
not a "rule" as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act. The
requirements for the preparation of an initial regulatory flexibility
analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA
is not required by the APA or any other law to publish a general notice
of proposed rulemaking.

Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).

This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.

As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the Congressional
Review Act, "any rule for which an agency for good cause finds that
notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest, shall take effect at such time as the
federal agency promulgating the rule determines." 5 U.S.C. 808(2). It
is in the public interest to schedule this substance immediately to
avoid an imminent hazard to the public safety. This temporary
scheduling action is taken pursuant to 21 U.S.C. 811(h), which is
specifically designed to enable the DEA to act in an expeditious manner
to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)
exempts the temporary scheduling order from standard notice and comment
rulemaking procedures to ensure that the process moves swiftly. For the
same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to
move quickly to place this substance into schedule I because it poses
an imminent hazard to the public safety, it would be contrary to the
public interest to delay implementation of the temporary scheduling
order. Therefore, this order shall take effect immediately upon its
publication. The DEA has submitted a copy of this temporary order to
both Houses of Congress and to the Comptroller General, although such
filing is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.